It begins as possibly another congressional browbeating of the FDA, but Sen. Sherrod Brown's missive to FDA commissioner Margaret Hamburg takes a turn that is at once insightful and possibly helpful. The topic is foreign APIs used in U.S.-made drugs. Brown was startled to learn from the FDA report, Pathway to Global Product Safety and Quality, that "80 percent of APIs were imported into the United States in 1998 alone...and it appears this trend has continued."
Brown cites such additional well-worn stats as fatalities associated with the 2008 contaminated heparin crisis and the recent GAO finding that the agency would require nine years for just one inspection each of foreign based pharma and API plants designated "high priority."
His letter eventually turns a corner, however, and morphs into some insightful requests and ideas, suggesting he has a much better handle on the pharma industry than the opening of his letter implies and perhaps than his congressional peers.
"As you look to develop international coalitions and strengthen partnerships with foreign nations [as the FDA report says], it is imperative that high-export nations--such as China, India, and Mexico--be included in these efforts," he writes. "What steps can your agency take to ensure that key exporters are not only included in the coalitions, but also abide by the resulting comparability and information sharing standards?"
Brown shows he is also keyed in on inspection shenanigans by asking how often FDA inspectors are denied access to foreign plants. He asks if the agency can refuse entry into the U.S. of APIs when inspectors have been turned away. "If it does not have such authority, is further legislation necessary?" the letter says.
Perhaps most significant is Brown's linkage of foreign APIs and drug shortages. "What role do import refusals from China--and other countries--play in the drug shortage crisis in the United States? Specifically, what percentage of drug shortages results from import refusals as compared to consolidation of pharmaceutical companies, economic decisions of a company to cease production, and problems in manufacturing?"
Those are two great questions, and many healthcare factions want them answered. But API makers and their drug-company customers are uniformly tight-lipped about their dealings. Even last fall's drug shortages summit convened by the American Society of Health-System Pharmacists and other organizations made little headway beyond getting promises from drugmakers that they will try harder to provide advance warning of shortages.
Here's hoping the FDA can get to the bottom of it. And that through FDA transparency, we'll all get to find out. - George Miller